Therapy device with current adjustment

ABSTRACT

An ECT system capable of focusing the electrical signals on a specific portion of the patient&#39;s brain is provided. The ECT system includes a means of applying unidirectional electrical signals and asymmetric electrodes for focusing the signals on the patient. A method of titrating an electro-convulsive therapy (ECT) system and a method of operating an ECT system are also provided. The method includes setting an initial current value, administering an ECT signal to the patient, determining if the seizure threshold has been achieved, and repeating as necessary until the seizure threshold is achieved.

CROSS REFERENCE TO RELATED APPLICATIONS

This application is a continuation of and claims priority to co-pendingU.S. patent application Ser. No. 15/696,872, entitled THERAPY DEVICEWITH CURRENT ADJUSTMENT, filed Sep. 6, 2017, which is a continuation ofU.S. patent application Ser. No. 14/262,234, entitled APPARATUS ANDMETHOD FOR ELECTRICALLY ADMINISTERED SEIZURE THERAPY USING TITRATION INTHE CURRENT DOMAIN, which issued on Oct. 17, 2017, as U.S. Pat. No.9,789,310, which is a division of U.S. patent application Ser. No.12/464,545, entitled METHOD AND APPARATUS FOR FOCUSING ELECTRICALSTIMULATION IN THE BRAIN DURING ELECTRO-CONVULSIVE THERAPY, which issuedon Apr. 29, 2014, as U.S. Pat. No. 8,712,532, the contents of all ofwhich are incorporated by reference herein in their entirety.

BACKGROUND Technical Field

The invention relates generally to the field of electro-convulsivetherapy. Specifically, the invention relates to a system and method ofadministering focused electro-convulsive therapy using titration in thecurrent domain.

Description of the Related Art

Seizure therapy was first recognized as a viable treatment forSchizophrenia in 1934 by the Hungarian neuropsychiatrist Von Meduna.Early seizure therapies used pharmacological inducement methods. Theseearly pharmacological methods were plagued by adverse side effects andunpredictability. In 1937, two Italian physicians, Cerletti and Bini,used electrical stimulation to induce the seizures for the seizuretherapy. The success of this method quickly led to its adoptionthroughout the world. The use of electrical stimulation to induceseizures is generally referred to as electro-convulsive therapy (ECT).

ECT was in widespread use in the 1940's and 1950's for treatment of manysevere mental health disorders including schizophrenia. However, thedevelopment of pharmacological alternatives to seizure therapy in themid-1950's signaled the decline of ECT use. Currently, ECT is onlysparingly used. However, due to limitations in the pharmacologicalalternatives, many psychiatrists have recognized the continuingviability of ECT and some have suggested that ECT use may be increasing.

Early ECT systems used standard 50 or 60 Hz sine wave electrical signalsas this type of signal was readily available on the consumer power grid.Once researchers had established a set of stimulus parameters that waseffective at producing seizures, there was no longer a need for ECTsystems to have parameter varying controls. Consequently, some early ECTsystems were not much more than a wall outlet plug, a voltage or currentknob, and an ON/OFF switch.

Eventually, the electrically induced signals were associated withadverse side effects in the patients such as confusion and amnesia. Thisled researchers to experiment with the stimulus signals to try to reduceor eliminate the side effects of the treatment. This research led to ECTdevices capable of providing a pulse waveform stimulus. Further,prominent ECT researcher, Paul Blachley, decided that, an optimal ECTdevice should incorporate the capability of monitoring bothelectroencephalograph (EEG) and electrocardiogram (ECG) signals, havethe ability to test the safety of the electrical circuit beforedelivering the stimulus, and have the ability to allow careful titrationto individuals' seizure thresholds. After design and testing efforts,the device envisioned by Blachley, which was known as the MECTA(Monitored Electro-Convulsive Therapy Apparatus) went on the market in1973, and readily grew in popularity over the following years.Additional improvements continued to be made to the MECTA system overthe years including safety improvements and the capability of continuoussignal monitoring during treatment.

Conventional ECT systems use alternating current (ac) signals.Typically, when using ac signals to generate seizures, symmetricelectrodes are used on the patient. Since the electrodes are symmetricand the current is bidirectional, the current distribution in thepatient will be essentially symmetric in the vicinity of bothelectrodes. Consequently, with conventional ECT systems, the ability tofocus the electrical signals on a specific portion of the patient'sbrain is extremely limited.

Also, in administering ECT, it is important to calibrate the ECT systemto the individual patient's seizure threshold. This process is calledtitration. The titration process is important to ensure that seizuresare generated in the most efficient way possible. Efficiently generatingthe seizures allows for more effective treatment and minimizes the sideeffects of the treatment to the patient. Conventional ECT systems use atotal charge energy titration method in which the pulse width or numberof pulses of the signals is manipulated until the patient's seizurethreshold is reached. Unfortunately, it is not possible in conventionalsystems to perform the titration process by varying only the current.However, the ability to perform a titration process by only adjustingthe current, may lead to more efficient determination of the patient'sseizure threshold and minimize adverse side effects to the patient.

The invention addresses these and other disadvantages of theconventional art.

SUMMARY

The disclosure provides an ECT system with the capability of focusingthe electrical signals on a specific portion of the patient's brain. Thesystem includes a means of applying unidirectional electrical signalsand asymmetric electrodes for focusing the signals on the patient. Thedisclosure also provides a method of operating an ECT system includingtitration in the current domain. Using the titration method of theinvention allows a more precise determination of the seizure thresholdand thereby, minimizes adverse side effects of the ECT treatment on thepatient.

BRIEF DESCRIPTION OF THE DRAWINGS

The above and other objects, features and advantages of the disclosurewill be more clearly understood from the following detailed descriptiontaken in conjunction with the accompanying drawings, in which:

FIG. 1 is a block diagram of an ECT system according to the invention;

FIGS. 2A and 2B are block diagrams of the delivery circuitry andhardware safety monitors of the system shown in FIG. 1;

FIGS. 3A through 6A are cross-sectional views of negative electrodesaccording to some embodiments of the invention;

FIGS. 3B through 6B are plan views of negative electrodes according tosome embodiments of the invention;

FIG. 7A is a cross-sectional view of a positive electrode according toan embodiment of the invention;

FIG. 7B is a plan view of a positive electrode according to anembodiment of the invention;

FIG. 8 is a flowchart of a method of providing Focal ElectricallyAdministered Seizure Therapy to a patient; and

FIG. 9 is a flowchart of a method of titrating an ECT system in thecurrent domain to determine a patient's seizure threshold.

DETAILED DESCRIPTION OF PREFERRED EMBODIMENTS

Example embodiments are described below with reference to theaccompanying drawings. Many different forms and embodiments are possiblewithout deviating from the spirit and teachings of this disclosure andso the disclosure should not be construed as limited to the exampleembodiments set forth herein. Rather, these example embodiments areprovided so that this disclosure will be thorough and complete, and willfully convey the scope of the disclosure to those skilled in the art. Inthe drawings, the sizes and relative sizes of components and regions maybe exaggerated for clarity.

It will be understood that, although the terms first, second, third,etc. may be used herein to describe various elements, components,regions, layers and/or sections, these elements, components, regions,layers and/or sections should not be limited by these terms. These termsare only used to distinguish one element, component, region, layer orsection from another element, region, layer or section. Thus, a firstelement, component, region, layer or section discussed below could betermed a second element, component, region, layer or section withoutdeparting from the teachings of the disclosure.

The terminology used herein is for the purpose of describing particularexample embodiments only and is not intended to be limiting. As usedherein, the singular forms “a,” “an” and “the” are intended to includethe plural forms as well, unless the context clearly indicatesotherwise. It will be further understood that the terms “comprises”and/or “comprising,” when used in this specification, specify thepresence of stated features, elements, and/or components, but do notpreclude the presence or addition of one or more other features,elements, components, and/or groups thereof.

Unless otherwise defined, all terms (including technical and scientificterms) used herein have the same meaning as commonly understood by oneskilled in the art to which this disclosure pertains. It will be furtherunderstood that terms, such as those defined in commonly useddictionaries, should be interpreted as having a meaning that isconsistent with their meaning in the context of the relevant art andwill not be interpreted in an idealized or overly formal sense unlessexpressly so defined herein.

FIG. 1 is a block diagram of an ECT system according to the invention.

Referring to FIG. 1, an ECT system 10 includes several connections tothe patient. The first connection is the ECT stimulus electrodes 12through which an ECT treatment signal is applied to the patient. The ECTsystem 10 also includes several patient monitoring inputs 13, 14 and 16that connect to the patient to receive EEG, ECG and/or OMS (opticalmotion sensor) signals, respectively.

The ECT system 10 further includes a user interface 18 through which theuser, typically a psychiatrist, interacts or interfaces with the ECTsystem 10. In one embodiment of the user interface, a plurality of knobs20 is included for setting the parameters that define the ECT signals.These parameters include the frequency of the signal, the pulse width ofeach individual pulse in the signal, the current level, and the durationof the ECT signal. According to some embodiments, the current of the ECTsignal can be adjusted independent of the voltage using the knobs 20 onthe user interface 18. The current may also be adjusted independentlyusing the other input means described below, such as the touch screen22.

The user interface 18 also includes a touch screen 22 which is atouch-sensitive display that allows the user to input commands to thesystem by touching certain portions of the screen. The system is menudriven so that the user can quickly and efficiently move through thecommand options. A display 24 is provided to display certain informationto the user both prior to and during treatment. A chart recorder 26provides a hard copy output of the patient monitoring signals. The ECTsystem 10 further includes a speaker 28 that sounds an audible alarmwhen certain failures occur in the system and as a safety featurewhenever the ECT section is activated. Indicators 30 are also providedas indicator lights for the user. A stimulus control section 32 isprovided to allow the user to initiate a treatment. A remote controlsection 34 may also be provided that allows the user to initiate atreatment while out of reach of the stimulus control section 32. Theremote control section 34, which works in conjunction with the paddles(334B, 336B of FIG. 2B), disables the (front panel) stimulus controlsection 32 so that when remote-control-equipped paddles are plugged intothe ECT system 10, a treatment cannot accidentally be initiated from thestimulus control section 32 on the user interface 18.

At the heart of the ECT system 10 is a computer system 36 whichorchestrates the operation of the system. The computer system includesfour processors: a system processor 38, a safety processor 40, a digitalsignal processor 42, and a front panel processor 44. The systemprocessor 38 is coupled to the knobs 20, the touch screen 22, thedisplay 24, and the chart recorder 26 of the user interface 18. Theknobs 20 and touch screen 22 are coupled to the system processor 38 viathe front panel processor 44 that emulates a standard keyboardinterface. Thus, the system processor communicates to and from the knobs20 and the touch screen 22 as it would communicate with a standard IBMkeyboard. Thus, the knobs 20 and the touch screen 22 can be replaced bya keyboard to provide input to the ECT system 10 for testing andmaintenance.

The system processor 38 is also coupled to a patient monitoring section46 through a sensor control block 48. The sensor control block 48includes logic that decodes signals received from the system processor38 and configures the patient monitoring section 46 into various modesresponsive thereto. These modes include the normal operational mode inwhich the patient monitoring signals are received from the patient andtest modes wherein the accuracy of the section is tested.

The computer system 36 also includes a safety processor 40. The safetyprocessor 40 is primarily responsible for creating and controllingdelivery of the stimulus waveform and coordinating the various safetytests and checks that are performed on and by the ECT system 10. Thesafety processor 40 is coupled to the system processor 38 via a serialinterface (SERIAL 1). The safety processor 40 is also coupled to asafety monitoring section 50 which includes equipment monitors 52 andsafety monitors 54. These monitors 52 and 54 monitor both the equipmentas well as the stimulus to determine whether or not the system isperforming within specification and, if not, to disable any furthertreatments.

The safety monitor 54 is further coupled to an ECT block 56 whichgenerates the ECT signal responsive to the safety processor 40. The ECTblock 56 is directly coupled to the timing circuits of an A-to-Dconverter 58 to receive a Z_PULSE signal that is generated during everysample taken by the A-to-D converter 58. The Z_PULSE signal is used bythe impedance-measuring portion of the ECT block 56 to measure patientimpedance. The A-to-D converter 58 digitizes the patient monitoringsignals received at inputs 13, 14 and 16 (i.e., EEG, ECG and OMS). Thisdigitized data is then operated on by the DSP 42 to filter out unwantedpower line frequency interference by the use of a frequency adaptivefinite impulse response (FIR) filter as well as to decimate thedigitized data for display.

Safety processor 40 is directly coupled to the speaker 28, theindicators 30, the stimulus control 32, and the remote control 34. Thesafety processor 40 initiates an ECT treatment sequence, under certainpredetermined conditions, responsive to inputs received from either thestimulus control 32 or the remote control 34. Both the ECT block 56 andthe safety processor 40 also actuate either the speaker 28 or theindicators 30 if certain conditions exist, e.g., internal self-testfailed. This provides redundant fault and “arming status” indicationsfor safety purposes.

The final section of the ECT system 10 is the isolated data outputsection 60. This section is coupled to the computer system 36 via threeserial ports: a synchronous serial port (SYNC SERIAL PORT) and twoasynchronous serial ports (SERIAL 2, SERIAL 3). The computer system 36is isolated from the isolated data output section 60 by opto-isolatorblocks 62 and 64. The opto-isolator block 62 is interposed between theDSP 42 and a digital-to-analog converter 66. The DSP 42 transmits thedigitized patient monitoring signals to the digital-to-analog converter66 in order that those signals may be observed by external equipmentcoupled to analog outputs 68. Similarly, the system processor 38communicates the display data via opto-isolator block 64 to an RS-232interface block 70, which provides two RS-232 serial output ports 72 toenable this data to be stored, displayed, or printed by an externalcomputer. The opto-isolators, 62 and 64, here protect the patient andthe operator from shock hazards that may occur due to, e.g., electricalfaults.

The construction and operation of the ECT system 10 is described ingreater detail in U.S. Pat. Nos. 5,755,744 and 6,014,587, which areherein incorporated by reference in their entirety.

FIGS. 2A and 2B are block diagrams of the delivery circuitry andhardware of the safety monitors of the system shown in FIG. 1.

Referring to FIGS. 2A and 2B, the three outputs of a pulse driver (+, −,and POWER) are connected to the center-tapped primary winding of a firsttransformer T1. The first transformer T1 is a step up transformer sothat the voltage across the secondary winding is equal to the turnsratio times the voltage across the primary. The current in thesecondary, on the other hand, is reduced by the turns ratio. In thepreferred embodiment, the turns ratio is equal to 16.6:1.

A relay R1 is interposed between the outputs of the secondary windingand the two paddles 334B and 336B. The optional remote control unit 338is shown connected between relay R1 and the paddles 334B and 336B.However, the optional remote control unit 338 is not required. When theoptional remote control unit 338 is not provided, paddles 334B and 336Bcould be simple electrodes that are used when the treatment is initiatedfrom the stimulus control section 32.

The relay R1 is used to switch a dummy load R7 into and out of thecircuit of the secondary winding of the first transformer T1. When therelay is in the position shown in FIG. 2B, the dummy load R7 is switchedinto the circuit and when the relay R1 is in its other position, thedummy load R7 is taken out of the circuit and the winding is connectedto the paddles 334B and 336B. The state of the relay R1 is controlled bya logic gate 382 whose output is connected to the coil of the relay vialine 340. The logic gate 382 includes two inputs 342 and 344 forreceiving a hardware shutdown signal HW_SD and a control signal CNTL2.The logic gate 382 switches from the dummy load to the patient, i.e.,the paddles, if the control signal CNTL2 is asserted and the hardwareshutdown signal HW_SD is not asserted. This provides the system with theability to shunt the pulse to the dummy load R7 under software controlas indicated by the assertion of the control signal CNTL2, which isunder control of the safety processor 40. The control signal CNTL2allows the system to perform an internal self-test in which apre-treatment ECT signal is applied to the dummy load R7 and thecharacteristics of the ECT signal are then examined by the safetyhardware and the system rendered inoperable if any of these safety testsfail.

The safety monitoring section also includes a second relay R2, which isused to either short out, or leave unshunted, a 5 Kohm resistor R8 inthe output circuit under certain test conditions. This 5 Kohm load isshorted by R2, thus effectively shorting the secondary winding of thefirst transformer T1 when a control signal CNTL3 is asserted. Thiscontrol signal is applied to the coil of relay R2 via input 346. The 5Kohm resistor and relay R2 are used during the self-tests of theinstrument's ability to measure static impedances at zero ohms and 5Kohms.

A second transformer T2 is used to measure the voltage delivered to thedummy load during pre-treatment testing. The voltage across the primaryof the second transformer T2 is stepped down to the secondary, which isthen measured by a voltage monitoring circuit 348. A current is providedto the secondary winding by an AC current source 350, which generates afixed current responsive to the Z_PULSE received on input 352. Thiscauses a current of approximately 40 □A through the secondary of thesecond transformer T2. Because the current AC amplitude is fixed, thenthe voltage measured by the voltage monitoring circuit 348 isproportional to the static impedance (of the patient or of the impedanceself-test resistor R8). The measured voltage DELIV_V is provided to thesafety processor 40 from the voltage monitoring circuit 348 on output354. A signal corresponding to the measured impedance IMP is provided bythe voltage monitoring circuit 348 to an amplifier 356 whose output isthen rectified by precision rectifier 358 and filtered by low passfilter 360. The output of low pass filter 360 is a signal Z on output362 that is proportional to the measured static impedance.

The circuits described above measure what is termed “static” impedance.Static impedance in the context of ECT is the impedance measured undertest conditions of very low currents applied to the patient (or testresistors). Static impedance changes little with continued applicationof the current used to perform the measurement. “Dynamic” impedance inthe context of ECT, on the other hand, is the effective impedancepresented by the patient's scalp and the paddle electrodes to theapplied treatment current. Dynamic impedance is the impedance observedat very high applied currents, where the scalp tissue exhibitsnon-linear impedance behavior. The dynamic impedance seen in ECT is muchlower than the static impedance seen in ECT, and furthermore, decreasesgenerally during the duration of the treatment. Dynamic impedance iscalculated by the system processor by dividing the delivered voltage bythe delivered current. Signal Z on line 362 is not used to obtaindynamic impedance.

The circuit also includes a third transformer T3, which is used tomeasure the current through the output circuit of the first transformerT1. The third transformer T3 is a (voltage) step up transformer whosesecondary is coupled to a current monitoring circuit 364 which measuresthe current through the output circuit. This measured current signalDELIV_I is then provided to the safety processor 40 on output 366.

The circuit also provides an energy monitor circuit. The energy monitorincludes an analog multiplier 388, a voltage-to-frequency converter 390,a two-stage counter 392 and an energy limit select circuit 394. Theanalog multiplier has two inputs: one of which is connected to thevoltage monitoring circuit 348 to receive the measured voltage signalDELIV_V; and the second input is connected to the current monitoringcircuit 364 to receive the measured current signal DELIV_I. The analogmultiplier then multiplies these two signals together to produce adelivered power signal DELIV_P on output 396. The delivered power signalis then provided to a voltage-to-frequency converter 390 which convertsthe voltage level of the delivered power signal to a clock signal havinga frequency proportional to that power signal level. The clock signal isprovided to a clock input of a counter 392, which, in the preferredembodiment, is implemented by cascading two binary counters. Thecounters produce a binary count that increments with each rising edge ofthe clock signal from the voltage-to-frequency converter 390. Thisbinary count is then provided to a maximum energy limit select circuit394 which compares the binary count to a preset limit. If the binarycount exceeds this preset limit, the circuit 394 asserts a signalENERGY_MAX on output 398 to indicate that the amount of energy deliveredto the patient during this treatment has exceeded a pre-selected limit.In the preferred embodiment, the pre-selected limit is adjustable withthe use of jumpers to allow for different limits to be set in differentcountries or under different conditions. It should be apparent that thevoltage-to-frequency converter 390 and counter 392 are but oneimplementation of what is essentially an integrator, which integratesthe delivered power signal DELIV_P over time. Other integrators, ofcourse, can be used.

The paddles 334B and 336B may be part of an optional remote controlpackage that allows the user to initiate an ECT treatment from thepaddles 334B and 336B. Otherwise, the user can only initiate a treatmentfrom the front panel ‘Start Treatment’ switch. One of the paddlesincludes a two-stage switch represented by switches S11 and S12 in FIG.2B. The first switch S11 initiates a pre-treatment test sequence.Actuation of the first switch S11 is detected by measuring the currentthrough the optional remote control unit. This is accomplished byswitching different resistances into the circuit according to whichswitch is actuated. The first switch S11 is normally open, as indicatedin FIG. 2B. In addition, the second switch S12 is normally in theposition shown. In this default state, a circuit is formed withresistors R9 and R10 across which a voltage is supplied by remotecontrol power supply 400. The current supplied by the power supply 400is detected by a current monitoring circuit 402 which is coupled to thepower supply 400 by a fourth transformer T4. The current monitor 402produces a signal RC_SENSE, which is proportional to the measuredcurrent supplied by the power supply 400. This signal RC_SENSE isprovided to a threshold detector 404, which compares the current levelof the signal RC_SENSE to determine whether the current level exceeds apredetermined amount. If insufficient current is detected, the circuit404 assumes that the remote control unit 338 is not connected. If thecircuit, however, detects this minimum current level, then the circuit404 switches the state of switches S13, S14 and S15 so as to disable thefront panel switch S16 so that a treatment cannot accidentally beinitiated from the stimulus control section 32 on the user interface 18.

If the test switch S11 is actuated, on the other hand, resistor R12 iscoupled in parallel with resistor R10, thereby presenting a differentload to the remote control power supply 400. This current is alsomeasured by the current monitor 402.

The treatment switch S12 actually corresponds to the second stage of thetwo-stage switch comprised of S11 and S12. Therefore, S12 can only beactuated if S11 is also actuated. If S12 is actuated (and thereforeS11), a circuit is formed with R9, R11 and light-emitting diode D3 of anopto-coupler. Passing a current through diode D3 causes a signal to beproduced by optical detector Q3, which is then passed on to the safetyprocessor as the TREAT_RELEASE signal through switch S13. This signalcan then be used to determine if the treatment switch S12 is releasedprior to the full treatment duration that was programmed by the frontpanel controls.

A bridge rectifier 380 may be interposed between the relay R1 and thepaddles 334B and 336B depending on the position of a relay R20. Theposition of the relay R20 is determined by the signal SIGNAL_DIR. Whenthe relay R20 is in the position shown in FIG. 2B (the first position),a bi-directional, or pulsed alternating current, signal is applieddirectly from the relay R1 to the paddles 334B and 336B. In other words,when the relay R20 is in the first position, the bridge rectifier 380 isbypassed. However, when the relay R20 is in the second position (theopposite position of that shown in FIG. 11B), the relay R1 is coupled tothe paddles 334B and 336B through the bridge rectifier 380, therebydelivering a unidirectional, or pulsed direct current, ECT signal to thepaddles 334B and 336B. When the unidirectional ECT signal is applied tothe paddles 334B and 336B, the paddle 334B can be referred to as apositive paddle and the paddle 336B can be referred to as a negativepaddle. Due to the varying response of the brain to the direction of thecurrent, the unidirectional ECT signal can be used to focus the ECTstimulus on specific portions of the patient's brain, thereby providingmore efficient treatment.

FIGS. 3A through 6A are cross-sectional views of negative electrodesaccording to some embodiments of the invention. FIGS. 3B through 6B areplan views of negative electrodes according to some embodiments of theinvention.

In conventional ECT systems, the electrodes attached to the paddles 334Band 336B are symmetric. In other words, the electrodes attached to thepaddles 334B and 336B are the same for both paddles. The electrodes inconventional systems are typically circular with a diameter of about 2inches. However, according to the invention, the electrodes attached tothe paddles 334B and 336B are asymmetric. In other words, the electrodeattached to the positive paddle 334B (the positive electrode) may bedifferent in one or more of size, shape, and area from the electrodeattached to the negative paddle 336B (the negative electrode). Accordingto some embodiments, both the positive and negative electrodes are madefrom solid 303 stainless steel. However, the positive and negativeelectrodes may be made from different materials. Also, the positiveelectrode may be made from a different material than the negativeelectrode.

Referring to FIGS. 3A through 6B, a negative electrode 600 includes anelectrical contact portion 602 and a patient contact portion 604. Theelectrical contact portion 602 electrically connects the negativeelectrode 600 to the negative paddle 336B. The patient contact portion604 of the negative electrode 600 is placed on the patient's scalpduring treatment along with the positive electrode 610 (as shown inFIGS. 7A and 7B) and determines the distribution of the electricalcurrent in the patient's brain. The electrical contact portion 602 maybe generally cylindrical in shape. According to some embodiments, theelectrical contact portion 602 is cylindrically shaped and has a heightof about 0.5 inches and a diameter of about 0.32 inches.

The patient contact portion 604 may be substantially rectangular inshape, with rounded corners. According to some embodiments, the patientcontact portion 604 may be rectangular with the length of the short axisof about 1 inch and the length of the long axis of about 2.5 inches. Thecorners may have a small radius of curvature as shown in FIG. 3B or agreater radius of curvature as shown in FIG. 4B. As an example, theradius of curvature of the patient contact portion 604 in FIGS. 3B and4B may be about 0.125 and 0.25 inches, respectively. The corners mayhave an even greater radius of curvature as shown in FIG. 5B, such thatthe sides of the patient contact portion 604 are substantiallysemicircular. As an example, the radius of curvature of the patientcontact portion 604 in FIG. 5B may be about 0.5 inches. According to apreferred embodiment, as shown in FIGS. 6A and 6B, the patient contactportion 604 may be substantially rectangular with short and long axislengths of 2 and 3 inches, respectively, with a radius of curvature ofthe corners of 0.25 inches.

FIG. 7A is a cross-sectional view of a positive electrode according toan embodiment of the invention. FIG. 7B is a plan view of a positiveelectrode according to an embodiment of the invention.

Referring to FIGS. 7A and 7B, the positive electrode 610 may include anelectrical contact portion 612 and a patient contact portion 614. Theelectrical contact portion 612 of the positive electrode 610 may besubstantially similar to the electrical contact portion 602 of thenegative electrode 600 described above. The patient contact portion 614of the positive electrode 610 may be substantially different in one ormore of size, shape, and area from the patient contact portion 604 ofthe negative electrode 600. For example, the patient contact portion 614of the positive electrode 610 may be substantially circular shaped witha diameter of about 0.75 inches.

FIG. 8 is a flowchart of a method of providing Focal ElectricallyAdministered Seizure Therapy to a patient.

Referring to FIG. 8, the first step in the method of providing ECT to apatient consists of applying electrodes to the patient's scalp. Whenasymmetric electrodes are used, the electrodes may be arranged on thepatient's scalp so as to focus electrical signals on a specific portionof the patient's brain. As an example, a negative electrode may bepositioned on a posterior portion of the patient's head and the positiveelectrode may be positioned on an anterior portion of the head. Further,the negative electrode may be larger than the positive electrode. Next,a titration procedure is performed on the patient. The titrationprocedure is used to estimate the seizure threshold, or the lowest doseof electricity needed to produce a seizure. Titration usually isconducted at the first treatment of a patient with an electricalstimulus administration that is sufficiently low so that most patientsdo not have a seizure. As an example, the first electrical stimulus maybe at a level at which a seizure would result in only about 15% of thegeneral population. If in fact no seizure occurs, one or more parametersof the ECT signal are changed and the modified stimulus is applied tothe patient. This process of applying the signal, determining if aseizure results, and adjusting the ECT signal is repeated until asatisfactory seizure is produced. Generally, the titration proceduremust be completed within five applications of the stimulus to thepatient in a single session due to limitations on the patient'sphysiology and the capabilities of anesthetic technology.

A titration procedure is desirable before administering ECT treatmentbecause there are marked individual differences among patients in theirseizure threshold. Using standard approaches to titration, at least a50-fold range has been identified in seizure threshold values. A gooddeal of this variability is due to individual differences in skullanatomy resulting in variability of current shunted away from the brainthrough the scalp and skull. Only a small portion of current in anypulse actually enters the brain. In the past, titrating dosage has beenprimarily manipulated in terms of the number of pulses; either bymanipulating the frequency of pulses (i.e. the number of pulses persecond) or the duration of the pulse train. Despite the fact that peoplevary in the amplitude of the pulse in their brain tissue, adjustment forthese individual differences has only manipulated the total number ofpulses the patient receives. However, titrating in the current domain,in accordance with embodiments of the invention, can be more efficientand require lower charge when determining the seizure threshold.Compared to traditional techniques, titration in the current domain mayresult in less severe cognitive side effects from the ECT treatment.

Two methods are generally used to determine if a seizure has beensatisfactorily produced during the titration procedure. Most modernprocedures use EEG signals to determine if a seizure has been produced.Typically, two channels of EEG monitors are connected to the patient tomonitor for seizures. The second method is to monitor for motorseizures. This may be done using an optical motion sensor attached tothe patient.

Once the titration procedure is completed and the seizure threshold isdetermined, the ECT system parameters are set to provide the desiredtreatment to the patient. Finally, the desired ECT signal isadministered to the patient to induce seizures.

FIG. 9 is a flowchart of a method of titrating an ECT system in thecurrent domain to determine a patient's seizure threshold.

Referring to FIG. 9, the method of titrating an ECT system in thecurrent domain includes first setting the parameters of the ECT systemso as to provide a low current initial ECT signal to the patient.Conventional ECT systems have a minimum current level of 500 mA.However, according to some embodiments of the invention, a minimumcurrent level of 100 mA may be used for titration in the current domain.Therefore, the low current initial ECT signal can be 100 mA. In the nextstep of the method, the low current initial ECT signal is administeredto the patient. Then, a determination is made as to whether thepatient's seizure threshold has been reached. If the seizure thresholdis reached, the method ends. If the seizure threshold is not reached,the parameters of the ECT system are set to provide an incrementallyhigher current ECT signal, the higher current signal is administered tothe patient, and a determination is made as to whether the patient'sseizure threshold is reached. This process continues until the patient'sseizure threshold is reached.

According to some embodiments of the invention, the current is doubledfor each successive application of the stimulus until the seizurethreshold is determined. Also, the current may be adjusted from about100 mA to about 800 mA.

According to embodiments of the invention, the titration method can beperformed by adjusting the current of the ECT signal rather than thenumber of pulses or the width of pulses as in conventional systems.Using the current titration method of the invention allows a moreprecise determination of the seizure threshold and thereby, minimizesadverse side effects of the treatment on the patient.

It should be appreciated that the above titration process may beembodied in an article of machine-readable media containing code that,when executed, causes the ECT system to perform these functions.

According to the invention, as described above, an ECT system includes arectification circuit to allow unidirectional, or direct currentstimulus to a patient. The ECT system also includes asymmetric positiveand negative electrodes to allow focused stimulus of specific portionsof the patient's brain.

According to some embodiments of the invention, a method ofadministering an ECT treatment to a patient includes adjusting thecurrent of an ECT signal independently from the voltage to allowtitration in the current domain. Therefore, a patient's seizurethreshold can be more efficiently and reliably determined.

The foregoing is illustrative of the invention and is not to beconstrued as limiting thereof. Although a few example embodiments of theinvention have been described, those skilled in the art will readilyappreciate that many modifications are possible in the exampleembodiments without materially departing from the novel teachings andadvantages of the invention. For example, several shapes and sizes ofelectrodes are specifically shown, but many more shapes and sizes ofelectrodes are possible. Accordingly, all such modifications areintended to be included within the scope of the invention as defined inthe following claims.

1. A device for inducing electro-convulsive therapy (ECT), the devicecomprising: a controllable signal generator that produces an ECTstimulus having a pulsed electric current component having a constantamplitude of less than 500 mA.
 2. The device of claim 1, in which theamplitude of the pulsed electric current component is approximately 100mA, and in which the controllable signal generator is structured toincrease the amplitude of the pulsed electric current component of theECT stimulus to a level above 100 mA.
 3. The device of claim 1, in whichthe amplitude of the pulsed electric current component is between 100 mAand 200 mA.
 4. The device of claim 1, in which the amplitude of thepulsed electric current component is between 100 mA and 400 mA
 5. Thedevice of claim 1, in which the amplitude of the pulsed electric currentcomponent is controllable by a user.